Causality, Severity, and Avoidability of Adverse Drug Reactions in Hospitalized Children: A Prospective Cohort Study

Background: Adverse drug reactions are an important cause of morbidity and mortality in all patients. Information regarding adverse drug reactions in the pediatric age group, especially with regard to the drugs involved and the clinical presentations is scanty. The aim of our study is to determine the incidence of adverse drug reactions and to study their features in terms of causality, type, severity, avoidability, drugs implicated and their clinical presentations. Methods: The study was carried out on patients admitted to the pediatric ward and the pediatric intensive care unit over a one-year period (January 1, 2013 to December 31, 2013). Patients either presenting with or developing an adverse drug reaction in the hospital were included in the study. Results: The incidence rate for adverse drug reaction causing hospital admission was 1.79% (95% CI 1.48, 2.16) whereas it was 1.23% (95% CI 0.97, 1.53) for children exposed to a drug during their hospital stay. Type B (bizarre or idiosyncratic type) was seen in 114 (62.6%) of the ADRs whereas 53 (29.1%) were of type A (augmented pharmacologic effect). Severe ADRs were seen in 25 (13.7%) of the total ADRs. ADR was responsible for the death of two patients. 15.4% were rated as avoidable. Anti-microbials were the most common group responsible for ADRs (43.4%), followed by drugs acting on the immune system (15.9%) and drugs acting on the nervous system (14.3%). The most common ADRs were metabolic (29.3%) followed by neurological (17.6%). Conclusions: Adverse drug reactions can occur in a substantial proportion of hospitalized patients with some of them being severe and potentially avoidable. Awareness among physicians should be encouraged regarding monitoring, documentation and notification of adverse drug reactions.